Biogen/AbbVie’s Zinbryta under review by PRAC

EMA PRAC (Pharmacovigilance Risk Assessment Committee) launched a review of Biogen/AbbVie’s Zinbryta (daclizumab). The product is intended to treat adult patients with relapsing forms of multiple sclerosis. The review follows the sudden death from liver failure of a patient who was being treated with the drug. The patient had been enrolled in an observational study. Additionally, four cases of serious liver injury were detected. Daclizumab, as a once-monthly injection, was granted approval by EMA and FDA in 2016.
(Source: Medscape)